Drug · Small Molecule

Gemcitabine

CI-DRUG-00000271Explore in graph →NCIt C66876 CHEMBL888 CIViC Approved

Regulatory

Approvals (52)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

health-canada-dpdRegulatory50 approval records from 2 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as ACT GEMCITABINE (DIN 02433117) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Aug 13, 2019	May 2, 2016	health-canada-dpd
CA Health Canada	—	Marketed in Canada as GEMCITABINE FOR INJECTION, USP (DIN 02407302) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince May 8, 2017	Jun 26, 2014	health-canada-dpd
CA Health Canada	—	Marketed in Canada as GEMCITABINE FOR INJECTION, USP (DIN 02407310) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Market

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 18 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	438	225	398	1,996	52	CA, US	Aug 4, 2011	1995-02
Malignant Pancreatic Neoplasm	Approved	Phase 4	109	50	69	560	3	US	Aug 4, 2011	1997-07
Malignant Bladder Neoplasm	Approved	Phase 3	39	14	25	126	1	US	Sep 9, 2025	1997-09
Malignant Lung Neoplasm	Approved	Phase 4	38	19	71	279

Curated evidence

Clinical evidence (43)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–43 of 43 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
MAGEH1 EXPRESSION1
Gemcitabine	Bile Duct Adenocarcinoma

Clinical trials

Trials with this intervention (2,012)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 2,012 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT03418038	Ascorbic Acid and Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma, CCUS, and Chronic Myelomonocytic Leukemia	recruiting	Phase 2	80	Mayo ClinicOTHER	1	Sep 28, 2026	clinicaltrials
NCT03734029	Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]	completed

Molecule

Record

Kind: Small Molecule
Mechanism: Ribonucleoside-diphosphate reductase RR1 inhibitor; DNA polymerase (alpha/delta/epsilon) inhibitor
Targets: 14 genes
UNII: U347PV74IL
Aliases: 1-(2-Oxo-4-amino-1,2-dihydropyrimidin-1-yl)-2-deoxy-2,2-difluororibose, 2'Deoxy-2',2'-Difluorocytidine, ACT GEMCITABINE, AJ-GEMCITABINE, AVGEMSI, DFdC, DFdCyd, Difluorodeoxycytidine, Gemcitabina, Gemcitabine, Gemcitabine Hydrochloride, GEMCITABINE HYDROCHLORIDE, GEMCITABINE SUN, Gemzar, INLEXZO, LY-188011, LY188011, NSC-613327

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (79)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01BC05	GEMCITABINE
DIN (Health Canada)	02230308

ERCC1 Underexpression2
Carboplatin + GemcitabineCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID10142 As part of a randomized phase III trial (USO-03012) in advanced NSCLC of gemcitabine vs. combination gemcitabine and carboplatin, protein expression levels for RRM1 (n=69) and ERCC1 (n=65) were evalua… (full text at CIViC) PMID 19884554 · Reynolds et al., 2009 · Open in CIViC	civic
Cisplatin + GemcitabineCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	submitted	EID6431 The Median Survival Time (MST) in patients with low ERCC1 mRNA levels was significantly longer in the overall population than in patients with higher ERCC1 levels (17.3 versus 10.9 months, log-rank 8.… (full text at CIViC) PMID 16980606 · Ceppi et al., 2006 · Open in CIViC	civic

RRM1 Underexpression11
Gemcitabine	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	accepted	EID5530 In this study, 229 tumors were analyzed for RRM1 expression. This resulted in 146 that were negative for RRM1 expression and 83 that were positive. These tumors were studied for a relationship between… (full text at CIViC) PMID 24647522 · Dong et al., 2014 · Open in CIViC	civic
Carboplatin + GemcitabineCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID10143 As part of a randomized phase III trial (USO-03012) in advanced NSCLC of gemcitabine vs. combination gemcitabine and carboplatin, protein expression levels for RRM1 (n=69) and ERCC1 (n=65) were evalua… (full text at CIViC) PMID 19884554 · Reynolds et al., 2009 · Open in CIViC	civic
Cisplatin + GemcitabineCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	accepted	EID2905 In the personalized therapy group of this study, patients received chemotherapy based on RRM-1 IHC expression levels, whereas the standard therapy group received non-customized chemotherapy. There wer… (full text at CIViC) PMID 24595080 · Nie et al., 2013 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	2	submitted	EID6432 22 patients were treated in the gemcitabine/cisplatin arm in this 3 arm clinical study. RRM1 mRNA levels seemed to have a highly significant effect on survival (P=0.0028) and time to progression (P=0.… (full text at CIViC) PMID 12789263 · Rosell et al., 2003 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	submitted	EID6436 Of the 100 patients in this study, only 81 of them were relevant to the study of both RRM1 and ERCC1. In those 81, there was a strong correlation between mRNA expression levels of RRM1 and ERCC1(Spea… (full text at CIViC) PMID 14977831 · Rosell et al., 2004 · Open in CIViC	civic
Gemcitabine + Platinum CompoundCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	submitted	EID6434 A correlation was observed between the expression levels of ERCC1, RRM1, and XPD across all patients. In patients with non small cell lung cancer, patients in the bottom quartertile of RRM1 levels ha… (full text at CIViC) PMID 15217961 · Rosell et al., 2004 · Open in CIViC	civic
Cisplatin + Gemcitabine + PaclitaxelCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Does Not Support Sensitivity Response	3	rejected	EID12043 The study began with a total of 443 patients with advanced NSCLC that were randomly assigned to either regimen A (paclitaxel and cisplatin with gemcitabine) or regimen B (cisplatin and vinorelbine). R… (full text at CIViC) PMID 27276561 · Papaemmanuil et al., 2016 · Open in CIViC	civic
Cisplatin + Gemcitabine + PaclitaxelCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Does Not Support Sensitivity Response	3	submitted	EID12044 The study began with a total of 443 patients with advanced NSCLC that were randomly assigned to either regimen A (paclitaxel and cisplatin with gemcitabine) or regimen B (cisplatin and vinorelbine). R… (full text at CIViC) PMID 23038758 · Vilmar et al., 2013 · Open in CIViC	civic
Gemcitabine + Paclitaxel + VinorelbineSubstitutes	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID5599 The study began with a total of 443 patients that were randomly assigned to either regimen A (Paclitaxel and cisplatin with gemcitabine) or regimen B ( cisplatin and vinorelbine). Of those patients, 2… (full text at CIViC) PMID 23038758 · Vilmar et al., 2013 · Open in CIViC	civic
Gemcitabine	Malignant Pancreatic Neoplasm	Predictive	B	Supports Sensitivity Response	3	accepted	EID5506 There were 68 patients enrolled in this study, 28 of which were treated with gemcitabine. Of those 28, 14 patients had a low RRM1 expression and 14 had a high RRM1 expression. Only the patients with … (full text at CIViC) PMID 19543324 · Akita et al., 2009 · Open in CIViC	civic
〃	Malignant Pancreatic Neoplasm	Predictive	B	Supports Sensitivity Response	3	accepted	EID5508 In this study, human pancreatic carcinoma cell line MiaPaCa2, which is a gemcitabine-sensitive cell line, was used for the establishment of chemoresistant cells MiaPaCa2-RG. Analysis for identifying g… (full text at CIViC) PMID 17131328 · Nakahira et al., 2007 · Open in CIViC	civic